Intensive dietary care
OtherIntensive dietary care following surgery for a craniopharyngioma with 3 visits 2 weeks prior surgery, and 3 months after surgery associated with a follow up every 2 weeks over a year after surgery
NCT Number: NCT07835165
Craniopharyngiomas are rare benign tumors that develop in the hypothalamic-pituitary region. Their prevalence is estimated at approximately 1 in 50,000 people in France.
The main symptoms associated with this condition are headaches and visual, neurological, and hormonal disorders. These symptoms appear when the tumors are large enough to compress adjacent structures (optic chiasm, pituitary gland, etc.).
The current standard treatment is surgical removal via endonasal approach or craniotomy, most often combined with adjuvant radiotherapy. One of the common postoperative complications is significant and rapid weight gain leading to obesity, which occurs in 26 to 61% of cases depending on the type of surgery.
These disorders can cause impulsive eating, hyperphagia, and persistent hunger, leading to deleterious metabolic consequences with an increase in comorbidities (diabetes, cardiovascular disease, joint problems, abnormal blood tests, asthma, etc.). They can also have psychosocial consequences, with a significant risk of professional and personal activity cessation during the first year after surgery due to asthenia and other possible postoperative complications (dizziness, discomfort, etc.).
In addition, this surgery alters the functioning of the pituitary gland, requiring lifelong hormone supplementation, particularly with hydrocortisone, a hormone that is essential for stress management and energy release. The optimal doses for these replacement therapies are difficult to determine. They are most often found at the end of the first year after surgery, which can then allow for a gradual resumption of normal social and professional activities and better control of health and dietary advice. This first year after surgery is therefore a pivotal year in the possible development of obesity in these patients, which justifies the importance of intensive dietary care offered to these patients as early as possible.
The investigators hypothesise that intensive dietary care could prevent weight gain and an increase in comorbidities in patients who have undergone surgery for craniopharyngioma.
The primary objective of this study is to evaluate the impact of intensive dietary care (intervention group in a prospective phase) versus usual care (control group in a retrospective pre-intervention phase) on the relative weight change in patients one year after the first resection of a craniopharyngioma.
The primary endpoint is the relative change in weight at 1 year post-surgery, i.e. the difference between the weight recorded at the last dietary consultation 1 year post-surgery and that recorded at the preoperative consultation, relative to the weight recorded at the preoperative consultation.
This study is a comparative, quasi-experimental before/after study, with a pre-control phase corresponding to patients who have undergone surgery for their craniopharyngioma and have received standard dietary management versus an interventional 'after' phase, corresponding to patients who will undergo surgery for their craniopharyngioma and who will receive intensive dietary management. The study is single-centre, with 50 patients to be recruited in the control group and 25 in the intervention group.
The expected results are to assess whether intensive dietary care (versus standard care) can limit weight gain in the year following the first removal of a craniopharyngioma, as well as its impact on socio-professional activities and the onset of comorbidities.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient already participating in an interventional study on craniopharyngioma.
Intensive dietary care following surgery for a craniopharyngioma with 3 visits 2 weeks prior surgery, and 3 months after surgery associated with a follow up every 2 weeks over a year after surgery
Time frame: 1 year
Difference between the weight recorded at the last dietary consultation 1 year post-surgery and that recorded at the preoperative consultation, relative to the weight recorded at the preoperative consultation
Time frame: 15 days
Difference between the weight recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation, relative to the weight recorded during the preoperative consultation
Time frame: 3 months
difference between the weight recorded during the dietary consultation 3 months after surgery and that recorded during the preoperative consultation, relative to the weight recorded during the preoperative consultation
Time frame: 1 year
Difference between the weight recorded during the dietary consultation 1 year after surgery and that recorded during the preoperative consultation, relative to the weight recorded during the preoperative consultation
Time frame: 15 days
Difference between the weight recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation
Time frame: 3 months
the difference between the weight recorded during the dietary consultation 3 months post-surgery and that recorded during the preoperative consultation
Time frame: 1 year
the difference between the weight recorded during the dietary consultation 1 year post-surgery and that recorded during the preoperative consultation
Time frame: 15 days, 3 months and 1 year
Wheigh collecting on a weighing machine
Time frame: 15 days
difference between the BMI recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation
Time frame: 3 months
difference between the BMI recorded during the dietary consultation 3 months after surgery and that recorded during the preoperative consultation
Time frame: 1 year
difference between the BMI recorded during the dietary consultation 1 year after surgery and that recorded during the preoperative consultation
Time frame: 15 days
the difference between the BMI recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation, relative to that recorded during the preoperative consultation
Time frame: 3 months
difference between the BMI recorded during the dietary consultation 3 months post-surgery and that recorded during the preoperative consultation, relative to that recorded during the preoperative consultation
Time frame: 1 year
the difference between the BMI recorded during the dietary consultation 1 year after surgery and that recorded during the preoperative consultation, relative to that recorded during the preoperative consultation
Time frame: 15 days, 3 months and 1 year
Number of patients in each BMI category (Calculation of BMI according to Quetelet's formula) 15 days, 3 months and 1 year after surgery
Time frame: 15 days, 3 months and 1 year
Number of patients in each BMI category according to the World Health Organisation classification (Calculation of BMI according to Quetelet's formula) at 15 days, 3 months and 1 year after surgery. Classification is as follow:
Time frame: 1 week or 15 days
Result of the calculation of divided the weight at today's consultation by the weight at the last consultation
Time frame: 15 days, 3 months, and 1 year
Number of patients presenting one or more biological abnormalities related to overweight or obesity (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
Time frame: 15 days, 3 months, and 1 year
Number of patients with abnormal fasting blood glucose levels
Time frame: 15 days, 3 months, and 1 year
Number of patients with abnormal total cholesterol levels
Time frame: 15 days, 3 months, and 1 year
Number of patients with abnormal HDL cholesterol levels
Time frame: 15 days, 3 months, and 1 year
Number of patients with abnormal LDL cholesterol levels
Time frame: 15 days, 3 months, and 1 year
Number of patients with abnormal triglyceride levels
Time frame: 15 days, 3 months and 1 year
Analysis of quality of life questionnaires (WHOQOL-BREF)
Time frame: 15 days, 3 months and 1 year
Assessment of total energy intake calculated from dietary intake, including proteins, lipids and carbohydrates.Unit of Measure: kcal
Time frame: 15 days, 3 months and 1 year
Analysis of the Dietary Behaviour and Eating Feelings Questionnaire (DEBQ)
Time frame: 15 days, 3 months and 1 year
Impedance measurement
Trial opening soon.
Get NotifiedAssistance Publique Hopitaux De Marseille
Other
A Comparative Historical-prospective "Before/After" Study Evaluating the Impact of Intensive Dietary Care on Weight Change and Biological Parameters in Patients Who Underwent Surgery for Craniopharyngioma During the First Postoperative Year
Acronym: CRANIODIET
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